Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
Toxicology
89d
Cleared
Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
Chemistry
24d
Cleared
Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Immunology
23d
Cleared
Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
Toxicology
51d
Cleared
Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
Chemistry
20d
Cleared
Aug 20, 2003
ELECYS SHBG CALCHECK
Chemistry
79d
Cleared
Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
Toxicology
54d
Cleared
Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
Toxicology
51d
Cleared
Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
Chemistry
63d
Cleared
Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
Chemistry
56d
Cleared
Aug 05, 2003
TINA-QUANT CRP (LATEX)
Chemistry
7d
Cleared
Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
Chemistry
23d
Cleared
Jul 17, 2003
FERRITIN GENERATION 2
Immunology
50d
Cleared
Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
Chemistry
29d
Cleared
Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
Chemistry
28d
Cleared
Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
Chemistry
26d
Cleared
Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
Chemistry
27d
Cleared
Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
Chemistry
19d
Cleared
May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
Hematology
66d
Cleared
May 12, 2003
ELECSYS LH CALSET II
Chemistry
18d
Cleared
Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
Toxicology
77d
Cleared
Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
Toxicology
80d
Cleared
Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
Hematology
22d
Cleared
Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Chemistry
7d
Cleared
Dec 06, 2002
ONLINE DAT II COCAINE II
Toxicology
66d
Looking for a specific device from Roche Diagnostics Corp.? Search by device name or K-number.
Search all Roche Diagnostics Corp. devices